The BUSCOPAN study: a randomized-controlled non-inferiority trial of a continuous butylscopolamine infusion versus placebo in patients with a renal colic not responding to oral non-steroidal anti-inflammatory drugs.

PURPOSE: To investigate whether placebo is non-inferior to continuous infusion of butylscopolamine in patients with renal colic. METHODS: We conducted a placebo-controlled, multicenter, double-blind randomized clinical trial (RCT) including 128 patients with renal colic (confirmed by ultrasound or CT-scan). Patients were randomized to receive either continuous IV butylscopolamine 100 mg/24 h or placebo (saline). Primary outcome is the amount of opioid escape medication used, measured in doses administered. Secondary outcomes are pain measured on a Numeric Rating Scale (NRS), side effects, and time of drug administration. Non-inferiority was assessed using linear regression with robust standard errors, with non-inferiority limit set at 0.5 units of escape medication. RESULTS: Median number of doses of escape medication was one in both groups. The number of extra doses in the placebo group compared with the butylscopolamine group was 0.05, with a 95% robust confidence interval (CI) of 0.38-0.47. Upper limit of the CI remained below the non-inferiority limit of 0.5 (p = 0.04). No differences in secondary endpoints were seen between the groups. CONCLUSION: Placebo is non-inferior to continuous IV butylscopolamine for pain relief in patients with renal colic. Based on this study and previous evidence, there is no role for continuous butylscopolamine IV in the treatment of renal colic. Trial NL7819.

High level of patient satisfaction and comfort during diagnostic urological procedures performed by urologists and residents.

OBJECTIVE: The aim of this study was to investigate how patients experience diagnostic urological procedures performed by urologists, junior residents and senior residents, and to assess the influence of procedure-related factors on patient experiences. METHODS: Data were collected during 222 procedures: 84 transrectal ultrasound-guided prostate biopsies (TRUSP; urologists n = 39, residents n = 45) and 138 urethrocystoscopies (UCS; urologists n = 44, residents n = 94) in six hospitals. Patient experiences were assessed using a questionnaire focusing on pain, comfort and satisfaction (visual analogue scale, 0-10) and communication aspects on a four-point Likert scale. Clinical observations were made to identify influencing factors. RESULTS: Median values for patient experiences across procedures were 10 (range 5-10) for patient satisfaction, 2 (0-9) for pain and 8 (0-10) for comfort. Generalized estimating equations revealed no significant differences between urologists, senior residents and junior residents in terms of experienced patient comfort, satisfaction or pain. Procedural time was longer for residents, but this did not correlate significantly with patient-experienced comfort (p = 0.3). In UCS, patient comfort and satisfaction were higher in the supine position for male and female patients, respectively (p < 0.01). In TRUSP, local anaesthesia resulted in a significant decrease in pain (p = 0.002) and an increase in comfort (p = 0.03). Finally, older patients experienced less pain and gave higher comfort and satisfaction responses than younger patients. CONCLUSIONS: Patients expressed high levels of satisfaction and comfort during diagnostic urological procedures. Experiences were not affected by the level of training, suggesting highly developed interpersonal and communication skills for residents in an early stage of residency training. Patients demonstrated significant preferences for local anaesthesia in TRUSP and performance of UCS in the supine position over the lithotomy position.

Training robotic surgery in urology: experience and opinions of robot urologists.

BACKGROUND: To answer the research questions: (a) what were the training pathways followed by the first generation of robot urologists; and (b) what are their opinions on the ideal training for the future generation? METHODS: Data were gathered with a questionnaire and semi-structured interviews in a mixed-method research design. RESULTS: The results show that training approaches differed from hardly any formal training to complete self-initiated training programmes, with all available learning resources. The median number of supervised procedures at the start of robot-assisted laparoscopy was five (range 0-100). Before patient-related console time, respondents indicated that the minimum training of robot trainees should consist of: live observations (94% indicated this as essential), video observations (90%), knowledge (88%), table assisting (87%) and basic skills (70%). CONCLUSION: The first generation of robot urologists used different training approaches to start robotic surgery. There is a need for a structured and compulsory training programme for robotic surgery. Copyright © 2014 John Wiley & Sons, Ltd.

Validation and implementation of surgical simulators: a critical review of present, past, and future.

BACKGROUND: In the past 20 years the surgical simulator market has seen substantial growth. Simulators are useful for teaching surgical skills effectively and with minimal harm and discomfort to patients. Before a simulator can be integrated into an educational program, it is recommended that its validity be determined. This study aims to provide a critical review of the literature and the main experiences and efforts relating to the validation of simulators during the last two decades. METHODS: Subjective and objective validity studies between 1980 and 2008 were identified by searches in Pubmed, Cochrane, and Web of Science. RESULTS: Although several papers have described definitions of various subjective types of validity, the literature does not offer any general guidelines concerning methods, settings, and data interpretation. Objective validation studies on endourological simulators were mainly characterized by a large variety of methods and parameters used to assess validity and in the definition and identification of expert and novice levels of performance. CONCLUSION: Validity research is hampered by a paucity of widely accepted definitions and measurement methods of validity. It would be helpful to those considering the use of simulators in training programs if there were consensus on guidelines for validating surgical simulators and the development of training programs. Before undertaking a study to validate a simulator, researchers would be well advised to conduct a training needs analysis (TNA) to evaluate the existing need for training and to determine program requirements in a training program design (TPD), methods that are also used by designers of military simulation programs. Development and validation of training models should be based on a multidisciplinary approach involving specialists (teachers), residents (learners), educationalists (teaching the teachers), and industrial designers (providers of teaching facilities). In addition to technical skills, attention should be paid to contextual, interpersonal, and task-related factors.

Virtual reality laparoscopic nephrectomy simulator is lacking in construct validity.

BACKGROUND AND PURPOSE: Several training models have been developed to improve surgeons' operative skills as well as patient outcomes. Before implementing these models in training programs, their usefulness and accuracy need to be assessed. In this study, we examined the ability of a laparoscopic nephrectomy (LN) virtual reality (VR) simulator to distinguish between different levels of expertise (construct validity). METHODS: Twenty-two novices (no LN experience), 32 intermediates (<10 LN procedures performed) and 10 experienced urologists (> or =10 LN procedures performed) performed the same retroperitoneal task on the LN VR simulator (Mentice, Sweden) three times, performing a practice task before and after the second time. Outcome parameters were time, blood loss, path length, and total score (combination of 62 different parameters). RESULTS: No significant differences were found between intermediate and experienced participants. Task 3 performance showed no significant difference between any of the groups. Both intermediates and experienced participants were significantly faster than novices on the first two tasks and had a better total score. Learning curves of intermediate and experienced participants were flat after task two. CONCLUSIONS: The LN-VR simulator did not distinguish between intermediate and experienced participants. The analysis of the learning curves suggests that the tasks measured dexterity in using the simulator rather than an actual improvement of operative skills. We conclude that the LN-VR simulator does not have sufficient construct validity and is therefore, in its present form, not suitable for implementation in a urologic training program.

Perceptions of surgical specialists in general surgery, orthopaedic surgery, urology and gynaecology on teaching endoscopic surgery in The Netherlands.

BACKGROUND: Specific training in endoscopic skills and procedures has become a necessity for profession with embedded endoscopic techniques in their surgical palette. Previous research indicates endoscopic skills training to be inadequate, both from subjective (resident interviews) and objective (skills measurement) viewpoint. Surprisingly, possible shortcomings in endoscopic resident education have never been measured from the perspective of those individuals responsible for resident training, e.g. the program directors. Therefore, a nation-wide survey was conducted to inventory current endoscopic training initiatives and its possible shortcomings among all program directors of the surgical specialties in the Netherlands. METHODS: Program directors for general surgery, orthopaedic surgery, gynaecology and urology were surveyed using a validated 25-item questionnaire. RESULTS: A total of 113 program directors responded (79%). The respective response percentages were 73.6% for general surgeons, 75% for orthopaedic surgeon, 90.9% for urologists and 68.2% for gynaecologists. According to the findings, 35% of general surgeons were concerned about whether residents are properly skilled endoscopically upon completion of training. Among the respondents, 34.6% were unaware of endoscopic training initiatives. The general and orthopaedic surgeons who were aware of these initiatives estimated the number of training hours to be satisfactory, whereas the urologists and gynaecologists estimated training time to be unsatisfactory. Type and duration of endoscopic skill training appears to be heterogeneous, both within and between the specialties. Program directors all perceive virtual reality simulation to be a highly effective training method, and a multimodality training approach to be key. Respondents agree that endoscopic skills education should ideally be coordinated according to national consensus and guidelines. CONCLUSIONS: A delicate balance exists between training hours and clinical working hours during residency. Primarily, a re-allocation of available training hours, aimed at core-endoscopic basic and advanced procedures, tailored to the needs of the resident and his or her phase of training is in place. The professions need to define which basic and advanced endoscopic procedures are to be trained, by whom, and by what outcome standards. According to the majority of program directors, virtual reality (VR) training needs to be integrated in procedural endoscopic training courses.